Why The Ambien Dosage For Women Is Lower

bottle of 10 mg ambien pillsBack in 2013, the United States Food and Drug Administration (FDA) announced that the recommended Ambien dosage for women should be halved.

That meant many women who were used to a dosage of 10 mg would only be prescribed 5 mg in the future.

But is that unfair to female insomniacs? Or is it justified considering the alleged increase in the risk of driving accidents in the morning?

To answer these questions, some background to the issue is needed.

Note: I’ve since updated this article to reflect the current guidance that the dosage can be increased if 5 mg is ineffective. See below for more information.

The new dosage

The FDA announced that it had told manufacturers of sleeping pills containing Zolpidem, such as Ambien, that they should reduce the recommended dosage.

So the standard Ambien dosage for women was reduced from 10 mg to 5 mg. And for extended release formulations, it was reduced from 12.5 mg to 6.25 mg.

For men, however, the FDA only recommended that doctors consider lowering the dosage to 5 mg and 6.25 mg respectively.

In addition, the FDA added that medical practitioners should advise patients that they are at a higher risk of impaired mental alertness.

Clinical trials showing worse driving skills

The reason behind the change is recent clinical trials and driving simulation studies. They found that some women perform certain tasks, such as driving, less well the morning after taking Ambien.

They found that women eliminate Zolpidem slower than men, though men also have a small chance of driving worse the next morning.

This was widely reported in the news, but what’s particularly interesting is the reaction from many people who rely on such sleeping pills to manage their insomnia.

How high is the risk really?

The comments sections of online news articles show a strong reaction from people who believe that they tolerate their higher Ambien dosage very well.

Many people feel they pose no potential threat to others from activities such as driving – especially those that don’t even drive!

Unsurprisingly, the manufacturers of Ambien, Sanofi, also released a statement saying that they believe Ambien to be safe. This is according to their clinical data and 20 years of use by millions of people.

Ambien has indeed had a great deal of testing by people. It’s the most popular sleeping pill available in many countries.

In 2011 in the United States alone, 44.8 million prescriptions were written for sleeping pills containing Zolpidem.

With so much apparently safe usage of the higher Ambien dosage, how bad could the results of these simulation studies have been?

Too much Ambien in the bloodstream the next morning

photo of a woman driving

The driving simulation studies found that if people have over 50 ng/mL Zolpidem in the blood, there’s an increased risk of having a driving accident.

The simulation studies involved 250 men and 250 women taking a dose of 10mg Ambien.

8 hours after dosage, they discovered that 15% of women and 3% of men exceeded the levels of 50 ng/mL. And 4 people had more than 90 ng/mL.

And those who took the extended-release 12.5mg had even higher incidents of elevated Zolpidem amounts in the blood: 33% of women and 25% of men.

What the manufacturer of Ambien says

ambien 10mg pill bottleThis issue isn’t new news, with the following statement appearing on Sanofi’s website:

Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem

They then go on to say:

Due to the risk to the patient and the community, discontinuation of Ambien CR should be strongly considered for patients who report a “sleep-driving” episode.

So should people be given a chance to continue with the old Ambien dosage and drive responsibly? Or should a potentially life-threatening risk be prevented outright?

Another statement on Sanofi’s website raises another point to consider:

As with “sleep-driving”, patients usually do not remember these events.

So if patients don’t always remember that they were sleep-driving, how can they be expected to report the episode?

Why insomniacs feel it’s unfair

There appear to be several reasons some people feel the change is unfair:

1. They feel they shouldn’t be punished because the drug can have dangerous effects on a minority of people.

2. The dosage should be tailored to each individual’s needs.

3. They believe some people don’t follow the guidance properly – timing, mixing with alcohol etc.

4. If they don’t get a good night’s sleep, they are even more at risk of having a driving accident.

5. Some people don’t drive anyway, so why should the rule apply to them?

While the frustration of people who Ambien helps sleep is understandable, the risks have to be balanced.

Although the FDA states that only a few dozen incidents of sleep-driving have been reported, they suspect there are many more unreported cases.

Update – a tailored approach

ambien pillsWhen this news first broke in 2013, it provoked disappointment and outrage because of the sudden and strict dosage change.

The FDA, however, later released updated advice allowing some room for tailoring the dosage to the individual.

The key points to note are that the wording changed from ‘recommended dose’ to ‘recommended initial dose’. So the dose can be increased if necessary.

The FDA website currently states the following advice:

The recommended initial dose of zolpidem extended-release (Ambien CR) is 6.25 mg for women and either 6.25 or 12.5 mg for men. If the lower doses (5 mg for immediate-release, 6.25 mg for extended-release) are not effective, the dose can be increased to 10 mg for immediate-release products and 12.5 mg for zolpidem extended-release. However, use of the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness.

The current Ambien label

If you’d like to keep up to date with any changes to the recommended dosage, you can do so by looking at the online FDA Ambien label.

At the time of writing, the section on dosage and administration looks like this:

image showing the current ambien dosage label

Your view

Do you find Ambien affects your ability to drive in the morning? Do you feel it was an unfair change in dosage?

Please leave a comment below with your thoughts.

114 CommentsLeave a comment

  • I have been taking 10 mg of ambien for 13 years with no side effects.
    I am 73 years old. Now my doctor will only prescribe 30 tablets every two months. My doctor said I should try and take them every other night or try other sleep aids that don’t work. Lack of sleep I don’t have any energy. I need my SLEEP!

  • Hi, Have any of you tried ordering Ambien online? Which site? I’m about ready to order online since my new Dr (took over practice from my retiring long-time Dr) thinks I can’t take the dose I’ve been getting for close to ten years. Lack of sleep is causing more migraines and irritability. Thanks!!!

  • Anonymous says:
    It is amazing how physicians with advanced psychiatric training are unwilling to practice their chosen profession-medicine- and be the decision makers in the health of their part. Yes, they may actually have to “perform” and take the time to add their names to a needless list for the FDA.
    The consequences for myself continue to surface but thank goodness I have found a neurologist who wants to treat my migraines and realizes that I need to get restful sleep. By the way I have been on Ambien for approximately 10 years with no adverse reactions.
    Sorry I had to change psychiatrists and am working to rid myself of any and all psychotropic medications so I don’t have the need for the “skills” of a psychiatrist.
    I will hopefully continue with Ambien so I may sleep and “drive safely.”
    0

  • I have taken 10mg of ambien for over 15 years. I have had no strange episodes. Only take when I’m in bed. I am over 65 a women and now for over a year dr will not prescribe. Have tried multiple sleep aides none work like ambien. Of course its unfair. We are not all the same. Some can tolerate it well. I don’t drink alcohol or do any other drugs. I could get drunk legally take a ton of benadryl but can’t take 10mg of ambien because I might fall?

  • I have Post Traumatic Stress Disorder from serving in the military. I am on many different medications, and Ambien is a life saver for me. Yes, I have migraines and other medical conditions, but all of these are worsened if I cannot sleep, and I just don’t sleep well or sometimes at all without Ambien. I have not had any episodes of sleep walking or sleep driving while on this medication. I am blessed to have a doctor at the Veteran’s clinic who understands this.

  • I went to the doctor today and was told no more ambien for me because I am over 65. I have never had any side effects and have taken 1/2 a pill for the past 8 years. This is discrimination and the FDA should be sued. I am going to find a new doctor. I work full time and just because I am 66, I am being punished because of a small minority of people who has experienced side effects. It is going to keep me from getting a decent night’s sleep. I am extremely angry about this situation.

  • Didn’t realize that I am
    It alone and how MANY people need this medication…. with NONE of the widely publicized..possible.. side effects ….. Ambien is the ONLy medication that has Ever helped me sleep … without druggy / nasty side effects…. it is so depressing to me that you can get Many sorts of mind altering .. so called.. Anti- Depressants….. YET …. I can only get a smaller than effective dose of Ambien because I am a woman. I take No Other medication…. tried Klonopin but to no use….. Need to sleep to be able , at 66 years old , to continue to earn a living…..Thanks for venue to whine… however…. what can be done to help ???

  • I need my sleep!!! It helps keep the migraines down. I have been on zolpideim for some years now different mgs 10, 6.5cr , 12.5cr due to the 10 not working as long within 2 to 4 hrs I would be up, yes up not sleep walking not sleep talking!! Wide up. Well I’m back on 6.5cr. 🤔. I’ve noticed if I get the correct amount of sleep the migraines are some what lessened for the month. I don’t care what you giving a man over a woman is it really helping the individual?

  • I have been using this for insomnia for 18 +/- years. I have NO SIDE EFFECTS what so ever. I get a good nights sleep and no drugged hangover, either. Now I have to try different drugs and none have done a thing except make me sick and deprive me of much needed rest. I believe patient and Doctor should be the ones to decide which drug works the best for the patient. I couldn’t tolerate REPATHA after 8 months or so. My body just pitched and awful fit of side effects. I had to start taking a drug for nephropathy, while on that stuff. I hope the idiots that made this decision for me will get syphilis and rot out their ignorant brains! POd ROYALLY

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